ICE COLD ANALGESIC- menthol gel 
NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient

Menthol 1 percentage

Purpose

Topical analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints associated with:

Warnings

For external use only.

Do not use:

with other topical pain relievers

with heating pads or heating devices

When using this product

do not use in or near the eyes

do not apply to wounds or damaged skin

do not bandage tightly

Stop use and ask a doctor if

condition worsens

symptoms last more than 7 days or clear up and occur again within a few days

skin or irritation develops

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

clean affected area before applying product

adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily.

children under 2 years of age: ask a doctor

Other information

Inactive ingredients

Water (Aqua), Camphor, Carbomer, FD&C Blue No.1, Isopropyl Alcohol, Methylchoroisothiazolinone, Methylisothiazolinone, Triethanolamine.

label

ICE COLD ANALGESIC 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76176-066
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
WATER (UNII: 059QF0KO0R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER 934 (UNII: Z135WT9208)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76176-066-01227 g in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/01/2020
Labeler - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. (530766098)
Registrant - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. (530766098)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Liyuan Daily Chemical Products Co., Ltd.530766098manufacture(76176-066)

Revised: 8/2020
Document Id: ad61ac93-a9ac-3626-e053-2a95a90a88bc
Set id: ad61ac93-a9ab-3626-e053-2a95a90a88bc
Version: 1
Effective Time: 20200801
 
NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.